The following data is part of a premarket notification filed by Aimago Sa with the FDA for Aimago Easyldi Microcirculation Camera (stand Plus Camera Arm), Aimago Easy Ldi Stand, Including 4-wheeled Stand Base An.
Device ID | K123216 |
510k Number | K123216 |
Device Name: | AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN |
Classification | Probe, Blood-flow, Extravascular |
Applicant | AIMAGO SA Parc Scientifique EPFL D 4TH FLOOR Lausanne, CH 1015 |
Contact | Marc Andre |
Correspondent | Marc Andre AIMAGO SA Parc Scientifique EPFL D 4TH FLOOR Lausanne, CH 1015 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-15 |
Decision Date | 2013-02-07 |
Summary: | summary |